AccurKardia’s AccurECG™ Analysis System Receives FDA 510(k) Clearance

The cloud-based, device-agnostic, fully automated ECG interpretation software platform can help cardiac monitoring companies expand access and provide the benefits of remote care to every zip code of the USA.

NEW YORK--(BUSINESS WIRE)--AccurKardia, a medical technology company delivering clinical-grade ECG interpretation software, announced today that its flagship product, the AccurECG™ Analysis System (“AccurECG” or the “System”), has been granted FDA 510(k) clearance. AccurECG™ is a cloud-based, device-agnostic and fully automated electrocardiogram (ECG) interpretation software platform.

The groundbreaking AccurECG™ software provides an array of benefits, such as beat-by-beat analysis, ventricular/supraventricular ectopic beat detection, heart rate measurement and automated interpretation of 13 different heart rhythms including sinus tachycardia, sinus bradycardia, atrial fibrillation and atrial flutter, among others. It provides Lead II analysis of data obtained from compatible ECG devices with wet electrodes such as holter monitors, event recorder and/or cardiac telemetry devices. The fully automated output of AccurECG™ improves clinicians’ review efficiencies and enables prompt treatment of patients, with results delivered in minutes. It is indicated for adults aged 22 and older.

Juan C. Jiménez, CEO of AccurKardia, remarked, “Receiving FDA 510(k) clearance is a significant milestone for us and we are extremely proud of what we have built. AccurECG™ is set to revolutionize remote cardiac care, making it more accessible and efficient across the Nation. By providing a device-agnostic, medical-grade solution with explainable output and no ‘black box’ approach, we aim to empower healthcare providers with accurate, fast, efficient and transparent ECG interpretation.”

The System's key benefits range from customizable outputs and configurations to seamless integration with established clinical workflows in an HIPAA compliant manner. Its cloud-based SaaS model assists cardiac monitoring companies by delivering a solution that can improve their service and response time for analysis.

AccurKardia’s offering helps improve clinical outcomes delivering a prompt analysis while minimizing false positives compared to traditional computational interpretation offerings¹ available in the market. Based on clinical data reported to FDA in a third-party clinical retrospective study, AccurECG™ has demonstrated an average aggregate sensitivity and specificity of approximately 96% and 99%, respectively, in detecting arrhythmias across its covered 13 heart rhythms.

Dr. Nav Razvi, Chief Medical Officer of AccurKardia, said, "Our team at AccurKardia is incredibly proud to achieve FDA 510(k) clearance for the AccurECG™ Analysis System. This clearance signifies a great stride forward in advancing remote cardiac care. The AccurECG solution can enable specialist-level ECG interpretation in communities and services that do not have ready access, as well as increasing the efficiency of workflow for busy clinical practitioners."

About AccurKardia

AccurKardia delivers automated clinical-grade ECG interpretation software to cardiac monitoring companies, thereby expanding access to the benefits of remote cardiac care to millions of patients worldwide. AccurKardia combines proprietary AI and non-AI based techniques to provide near-real-time ECG analytics in the cloud, on device, and at the edge. For more information about AccurKardia, please visit: https://www.accurkardia.com/.

¹ https://europepmc.org/article/med/17531257.